D-0814-2026 Class II Ongoing
FDA drug recall D-0814-2026 was initiated by Baxter Healthcare Corporation on August 6, 2026 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Reason for Recall
CGMP Deviations
Distribution Pattern
US Nationwide; Puerto Rico; and Chile.
Code Information
Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.